1. Field of the Invention
The present invention relates generally to the field of orthotic devices and appliances; more particularly to orthotic devices and appliances useful for restoring movement to a connective joint of a mammalian body; and still more particularly to orthotic devices and appliances used to reverse contractures due to immobility and neurological dysfunction of a human patient""s hand and fingers.
2. Background Discussion
Webster""s New Collegiate Dictionary defines xe2x80x9corthoticsxe2x80x9d as xe2x80x9ca branch of mechanical and medical science that deals with the support and bracing of weak or ineffective joints or muscles.xe2x80x9d
Orthotic devices and appliances, commonly referred to just as xe2x80x9corthoticsxe2x80x9d (in spite of the broader dictionary definition of orthotics), have been utilized for many years by physical therapists, occupational therapists, and certified orthotic fitters to assist in the rehabilitation of loss of range of motion (LROM) of patients"" joints and associated limbs or adjacent skeletal parts of the patients"" body.
Orthotics, as well as splints, have been designed both to maintain and to restore the range of bodily motion due to LROM. Such loss of range of motion may, for example, be caused by traumatic injury, joint or limb surgery, contracture due to immobilization caused by neuromuscular disorders (e.g., stoke and closed head injury) and other disease processes that significantly limit a patients ability to use a joint for normal activities of daily living (ADL).
Two fundamentally different types of contractures exist which clinically should have two different treatment protocols. The difference in these two types of contractures is the basis for the clinical techniques and design of the orthotics of the present invention that will be described below.
A first one of these two fundamentally different types of contracture may be defined as a fixed, high resistance of muscle to passive stretch resulting from fibrosis of the muscles and joints, or from disorders of the muscle fiber resulting in LROM, for example, of a patient""s hand and fingers. In this regard, Webster""s Dictionary defines xe2x80x9ccontracturexe2x80x9d as xe2x80x9ca permanent shortening (as of muscle, tendon and scar tissue) producing deformity or distortion.xe2x80x9d
This first type of contracture is usually due to trauma, injury, or surgical intervention affecting the joint, as may be typical of sports injuries and the treatment thereof. As the injured tissue heals, edema, post trauma or surgically affected tissue regeneration and other natural healing processes result in fusing together of what were, prior to the trauma, separate, pristine connective tissues, that is, the collagen fiber matrix, capable of easily gliding over one another, as is needed for normal joint movement and related muscle elongation.
However, post-trauma, this collagen fiber matrix becomes random and irregular, and neither elongates nor stretches compared to non-traumatized collagen fibers. This fusing-together or adhesion of connective tissue structures (e.g., ligaments, tendons, synovial membrane, fascia and fibrous joint capsules) is the result of the tissues being invaded by developing undifferentiated scar between adjacent tissue, thereby diminishing or preventing the mutual gliding after early healing of the trauma or post-surgical trauma has been accomplished.
This post-trauma matrix condition, as well as the above-mentioned normal matrix condition, is depicted and discussed in U.S. Pat. Nos. 5,891,068 and 6,001,074 to John P. Kinney, one of the present inventors. These two patents are hereby incorporated in their entirety in this application.
Such fusing together of connective tissue is a leading cause of lags (a non-specific indictment of the motor system""s failure to move the affected joint through the full available passive range) relating to tendon gliding, depending on their strategic placement in reference to structures crossing the joint.
With limited mobility and associated extensor muscle atrophy, combined with the formation of adhesions and scar tissue in the form of a significantly increased number of joined fiber matrix junctions, the muscle fibers become shortened.
The restoration of full range of motion where fibrosis of the muscle fiber with scar tissue and adhesions are present requires that the adhesions and scar tissue or fused fiber matrix junctions be xe2x80x9cworked throughxe2x80x9d or broken to restore normal functional elongation or stretch.
The term xe2x80x9cno pain, no gainxe2x80x9d (of increased range of motion) is associated with the process of breaking through joined or fused fiber matrix junctions to restore full elongation of the connective tissue, tendons and muscles associated with the trauma-affected joint.
Heretofore known orthotics are primarily designed to treat this first type of contracture, but have also been used to treat contractures caused by immobility and neurological dysfunction (described below). However, such orthotic devices are not, as far as is known by the present inventor, best suited for such additional purpose.
The second and very different type of contracture results from joint immobilityxe2x80x94not joint-related trauma or surgical repair of a joint. Contracture resulting from immobility is simply a shortening and thickening of the connective tissue, tendons and muscles that restrict the ROM of a joint. In such situations, the muscle fibers still retain their original uniform shape and there are no adhesions or scar tissue or significantly increased joined fiber matrix junctions to break through in order to restore full range of motion.
In contrast to trauma-caused contractures, contractures due to immobility do not need a xe2x80x9cno pain, no gainxe2x80x9d approach to restore the normal range of motion, and, in fact, such an approach can actually do more harm than good. As mentioned above, the collagen fibers of a contracture due to immobility are simply shorter and thicker, and will respond to appropriate stretching techniques and motion of the joint to restore LROM. The stretching technique usually used for contractures caused by immobility is Range Of Motion (ROM) Therapy and the use of Low-Load Protracted Stretch/Stress (LLPS) or xe2x80x9cextended stretchxe2x80x9d static or dynamic orthotic devices.
According to authors Kenneth R. Flowers and Susan L. Michlovitz in their article titled xe2x80x9cASSESSMENT AND MANAGEMENT OF LOSS OF MOTION IN ORTHOPEDIC DYSFUNCTIONxe2x80x9d (published in Postgraduate Advances in PHYSICAL THERAPY, American Physical Therapy Association, 1988 II-VIII), Total End Range Time (TERT) in conjunction with LLPS is the key to restoring full ROM.
All contractures, whether caused by injury, surgery, or immobility, limit range of motion of the affected joint and make simple activities of daily living, such as eating and self-dressing, more difficult, if not impossible. Moderate to severe contractures can be debilitating, and can leave afflicted individuals unable to care for themselves in the most basic daily living tasks. Even mild contractures due to immobility can progress to severe contractures if proper intervention is not prescribed and implemented so long as the immobility continues. The main function of my new and more effective orthotic devices is to treat contracture due to immobility-not trauma related to surgery or injury.
The above-cited Kenney patents disclose a variety of orthotic devices particularly useful for treating contractures of arms, hands, legs, feet, neck and back due to immobility.
The main function of my new and more effective orthotic devices is to treat contracture due to immobility-not trauma related to surgery or injury. In this regard, contractures and other hazards of immobility are one of the ten current highest health care costs in America that are totally preventable. This puts the health risks associated with immobility in the same category as cigarette smoking, alcohol and drug abuse, and automobile accidents in financial impact on American health care costs.
Recent managed care cost reimbursement decisions have, however, drastically limited professional therapeutic treatment for conditions, including immobility related conditions, which would otherwise be expected to respond favorably to professional rehabilitation therapy. Such managed care decisions have not only very substantially reduced the overall lengths of reimbursable therapy times for all types of patient conditions requiring professional therapeutic rehabilitation treatment, but have also put cost-reduction pressure on the manufacture and sale of therapeutic equipment and orthotic devices and appliances.
For these and other reasons, the present inventors have devised an improved orthotic device for treatment of contractures of the hand and fingers that is readily adapted for use with either a left hand or a right hand. The main function of our improved orthotic devices is to treat contracture due to immobilityxe2x80x94not due to trauma related to surgery or injury. Thus our improved orthotic device is uniquely appropriate for contractures due to immobility where neurological dysfunction is present in a patient""s hand and fingers.
Our universal hand orthotic device, easily adapted for use with most sizes of either a left hand or a right hand, will importantly reduce costly inventory requirements for therapeutic facilities and is expected to result in cost savings for patients requiring such devices and for their associated health care provider.
In accordance with the present invention, there is provided a universal orthotic device for treating contractures of either a patient""s left hand or right hand. As such, the device may be considered an ambidextrous hand orthotic device. The universal hand orthotic device of the present invention comprises a manually bendable, thin metal splint element having an elongate central, wrist support region. An elongate hand support region extends sidewardly from an upper end of the central region at an angle, xcex1, of between about 75 and about 80 degrees, and more preferably about 77 degrees, relative to a longitudinal axis of the central region.
A first ear projects to one side of a lower end of the splint element central region and a second ear projects to an opposite side of the lower end of the central region, the first and second ears being manually bendable relative to the central region to enable the splint element to fit at least partially around either a patient""s left wrist or a patient""s right wrist according to the intended use of the device.
The first and second ears each include an enlarged outboard end region joined to the central region by a smaller, necked-down region having a width parallel to said central region longitudinal axis of between about 0.5 and about 0.75 inches.
The splint element is substantially planar in shape before any bending of the first and second ears, and is preferably constructed from a relatively soft aluminum alloy having a sheet thickness of between about 0.040 and about 0.0938 inches.
It is preferred that the central region of the splint element have a width of about one inch and the hand support region have a width of about 0.5 inches. Each of the first and second ears preferably extend about 2.25 inches from the longitudinal axis of the central region. The splint element has a preferred overall height between about 7 and about 7.5 inches along the central region longitudinal axis.
The splint element is preferably disposed between first and second, relatively soft pads of a closed cell plastic material. The pads are shaped to generally follow the shape of the splint element and are cemented together around the splint element to form a padded splint assembly having a preferred thickness of about 0.375 inches.
The device includes a padded fabric mitt configured for receiving the splint element, the mitt including closure means for retaining the splint element in the mitt. At least one strap, preferably a plurality of straps, is attached to the mitt for enabling the releasable attachment of the mitt to a patient""s wrist and hand. Claim 17. The exterior of at least hand regions of the padded mitt are formed of a smooth, non skin irritating fabric. Preferably further included as part of the device is at least one resilient cylinder configured for detachable attachment to a finger-grip region of the mitt.
A universal hand orthotic device for treating contractures in either of a patient""s left hand or right hand thus comprises a manually bendable splint element constructed from a relatively soft aluminum alloy having a sheet thickness of between about 0.040 and about 0.0938 inches. The splint element has an elongate central, wrist support region with an elongate hand support region projecting sidewardly from an upper end of the central region at an angle between about 75 and about 80 degrees, relative to a longitudinal axis of the central region, a first ear projecting to one side of a lower end of said central region, and a second ear projecting to an opposite side of the lower end of said central region. The first and second ears being manually bendable relative to the central region to configure the splint element to fit at least partially around either a patient""s left wrist or a patient""s right wrist according to the intended use of said device. The first and second ears each include an enlarged outboard end region joined to the central region by a necked-down region having a width parallel to the central region longitudinal axis of between about 0.5 and about 0.75 inches.
The splint element has an overall height between about 7 inches and about 7.5 inches along said central region longitudinal axis, wherein said splint element central region has a width of about one inch, wherein said splint element hand support region has a width of about 0.5 inches and wherein each of said first and second ears extend about 2.25 inches from the longitudinal axis of said central region.
First and second, relatively soft flat pads constructed from a closed cell plastic foam material having a thickness of at least about 0.188 inches are included, the splint element being disposed between the first and second pads to thereby form a padded splint assembly. The first and second pads are contoured to generally follow the shape of the splint element and are cemented together around said splint element.
A padded fabric mitt is included for receiving the padded splint assembly the mitt including closure means for retaining the padded splint assembly in the mitt. The exterior of at least hand regions of said mitt are formed of a smooth, non skin irritating fabric. At least two straps are attached to the fabric mitt for enabling the releasable attachment of the mitt to a patient""s wrist and hand.
Included is a plurality of resilient cylinders of increasing diameters configured for detachable attachment to a finger-grip region of the mitt.